An Italian medical device manufacturer wanted to conduct a post-market clinical trial abroad to obtain marketing data quickly. A contract research organization proposed conducting the randomized controlled trial at an investigational site in an extra-EU country to maximize resources and expedite the 6-7 month timeline for analyzed data. The CRO planned to translate and adapt the study documents to local requirements, monitor the site, obtain ethics approval, manage products on site, and analyze data remotely according to good clinical practice to meet the client's goals in a cost-effective manner.

1. CRO4Q
Contract Research Organization
Best practice
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2. Case 4:
Planning and management of a clinical trial abroad
• A post-market Medical Device clinical trial in an extra-EU country
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3. Client:
An Italian manufacturer of Medical Devices standing on the international
market.
Client’s aims:
Design and conduct of a clinical study post-market as quickly as possible.
Specific advanced requirements:
 Randomized clinical trial
 Clinical data to be spent directly for marketing purposes
 Urgency to receive analyzed data (6-7 months)
 Marketability, traceability and maximum transparency of collected data
 Absolute compliance with Good Clinical Practice
Case 4
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4. Proposed solution:
• Scientific conception and study design of the research project from the
scientific literature and the data of the producer-client
• Drafting the study protocol, CRF and additional documents for the Ethics
Committee
• Recruitment of an investigational center in an extra EU country to maximize
resources and time
• Documentation translation and adaptation to local requirements
• Study conducting according to GCP
• Data analysis and clinical-statistical reporting
Case 4
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5. Methods and tools:
• Strong and consolidated partnership in the country
• Adaptation and certified translation into the local language of all the
documentation of the study in accordance with local requirements
• Site recruitement and site training
• Site monitoring
• IEC approval
• Logistical management of experimental products
• Conduct in accordance with GCP
• Remote data management
• Data analysis performed by the internal biostatistician team
• Planning and development of a Clinical and Statistical final report.
Case 4
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6. Advantages of conducting a post-market MD clinical trial abroad:
• Clear and essential rules for clinical trials with medical devices
• Direct and clear relationship with regulatory authorities and ethics
committees
• Same approach to ethical and scientific evaluation of the study as in EU
• Qualified and helpful investigators
• Modern and “western” clinical structures (with fast internet connection)
• High flow of patients willing to be involved in a clinical trial
Case 4
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7. Case 4
ANALISYS AND REPORTING (3 weeks)
Close-out Data analisys Reporting
RUNNING TRIAL (3 months)
Enrolling and follow up visits
START UP (6 weeks)
Site recruitment and
negotiation
IEC approval
Logistical management of
experimental products
PLANNING (6-8 weeks)
Scientific planning and
documents drafting
Review and translation
Data collection system
implemntation
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8. Client’s satisfied aims
Case 4
• Optimized timing according to objectives and deadlines
• Scientific and methodological rigor of the collected data,
supported by the maximum optimization of resources (30%
costs’ reduction)
• Clear and effective reporting in full compliance with the
goals set by the client
• Study conducted in accordance with the GCP
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